Advertise With UsAdvertise on our extensive network of industry websites and newsletters.
Get the PBR newsletterSign up to our free email to get all the latest PBR
news.Duska Therapeutics, a specialty pharmaceutical company, has submitted its pivotal Phase III ATPace clinical trial protocol for review under a special protocol assessment procedure with the FDA.
Subscribe to our email newsletter
Subject to securing an agreement with the FDA, Duska intends to initiate a single, prospective, double-blind, placebo-controlled and randomized Phase III clinical trial with its lead product ATPace.
This trial is aimed at demonstrating clinical safety and efficacy of ATPace in treating paroxysmal supraventricular tachycardia (PSVT), in emergency room patients. Upon successful completion of the trial, Duska intends to file a new drug application.
ATPace, a stable liquid formulation of adenosine 5′-triphosphate (ATP) for intravenous injection, is an investigational drug for the acute termination of PSVT. Duska believes that the initial dose of ATPace will be significantly more efficacious than the initial labeled dose of adenosine in terminating PSVT.
James Kuo, Duska’s CEO, said: “The request for a special protocol assessment represents a significant milestone in the development of ATPace. We believe that the Phase III clinical trial with ATPace should demonstrate the safety and efficacy of our drug in PSVT.”